NCT01911195

Brief Summary

Currently it is unknown how the human brain reorganizes its network organization to generate conscious experience and cognitive activity after a period of unconsciousness. Therefore, the purpose of this study is to assess how cognitive activity is reconstructed after general anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to consciousness and full cognition is a complex process that occurs over an extended period of time. Specifically, the investigators hypothesize the following order of cognitive reconstitution: responsiveness to command, attention, complex scanning and visual tracking, working memory, and executive function. Volunteers will be healthy participants who are anesthetized with commonly used anesthetic drugs as well as a non-anesthetized group to control for circadian influences. A total of 60 subjects will be recruited for this study. All subjects (male and female) will perform basic tests for cognition on a laptop computer at 30-minute intervals during this study. The testing battery to be administered was assembled to assess multiple cognitive functions in order to determine whether and how cognitive processes return to baseline function. Electroencephalogram (measuring brain electrical activity) data will be monitored and recorded during both anesthesia and cognitive testing, for subsequent analysis. This study is significant because it could lead to a better understanding of the neural correlates of human consciousness, as well as normal and abnormal conscious state transitions (including barriers to such transitions).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2015

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

July 21, 2013

Last Update Submit

February 14, 2024

Conditions

Postoperative Cognitive Dysfunction

Keywords

General anesthesiacognitionconsciousness

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive scores

    Neurocognitive battery performed on computer

    Three hours following emergence from general anesthesia

Secondary Outcomes (1)

  • Brain network connectivity

    Three hours following emergence from general anesthesia

Study Arms (2)

Control Group: Cognitive Testing

ACTIVE COMPARATOR

Control arm will receive cognitive testing only without undergoing general anesthesia

Other: Control Group: Cognitive Testing

ISOFLURANE- Experimental Arm

EXPERIMENTAL

Experimental arm will receive cognitive testing before and after general anesthesia

Drug: ISOFLURANE- Experimental Arm

Interventions

ISOFLURANE- Experimental ArmDRUG

The experimental group will be given the anesthetic isoflurane for three hours, and will undergo cognitive tests immediately following emergence from general anesthesia while connected to an EEG machine.

ISOFLURANE- Experimental Arm
Control Group: Cognitive TestingOTHER

The control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia.

Control Group: Cognitive Testing

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy 20-40 year old volunteers,
  • American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
  • Body mass index \< 30 kg/m2,
  • Easily visualized uvula,
  • With anticipated equal recruitment of males and females.

You may not qualify if:

  • Physical signs suggestive of difficult airway (e.g., mouth opening \<3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
  • History of obstructive sleep apnea,
  • Reactive airway disease,
  • Neuropsychiatric disorders,
  • History or current use of psychotropic medications,
  • Current tobacco and alcohol use,
  • History of hypertension or current medication for blood pressure control, cardiovascular disease or arrhythmias,
  • Positive urine toxicology screen,
  • History of reflux,
  • Pregnancy,
  • Family history of problems with anesthesia (including but not limited to malignant hyperthermia),
  • Sleep disorders,
  • History of postoperative nausea/vomiting or motion sickness,
  • Allergy to eggs, egg products or soy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Mashour GA, Palanca BJ, Basner M, Li D, Wang W, Blain-Moraes S, Lin N, Maier K, Muench M, Tarnal V, Vanini G, Ochroch EA, Hogg R, Schwartz M, Maybrier H, Hardie R, Janke E, Golmirzaie G, Picton P, McKinstry-Wu AR, Avidan MS, Kelz MB. Recovery of consciousness and cognition after general anesthesia in humans. Elife. 2021 May 10;10:e59525. doi: 10.7554/eLife.59525.

    PMID: 33970101BACKGROUND

  • Labonte AK, Kafashan M, Huels ER, Blain-Moraes S, Basner M, Kelz MB, Mashour GA, Avidan MS, Palanca BJA; ReCCognition Study Group. The posterior dominant rhythm: an electroencephalographic biomarker for cognitive recovery after general anaesthesia. Br J Anaesth. 2023 Feb;130(2):e233-e242. doi: 10.1016/j.bja.2022.01.019. Epub 2022 Feb 17.

    PMID: 35183346DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • George A Mashour, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Michael Avidan, MBBCh

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Max Kelz, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Mathias Basner, MD, PhD, MSc

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

February 9, 2015

Study Completion

February 9, 2015

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

US(3)